LTP001 for Pulmonary Arterial Hypertension
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Novartis Pharmaceuticals
Must be taking: PAH therapies
Disqualifiers: Cardiac abnormalities, Hypersensitivity, others
Trial Summary
What is the purpose of this trial?A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, it mentions that participants in Part B should be on stable doses of standard PAH therapies, so you may need to continue your current PAH treatment.
What data supports the effectiveness of the drug LTP001 for treating pulmonary arterial hypertension?
The research does not provide direct evidence about LTP001, but it mentions that similar drugs like riociguat and ambrisentan have shown effectiveness in improving outcomes for pulmonary arterial hypertension, suggesting that LTP001 might also be effective.
12345Eligibility Criteria
This trial is for healthy males and females who can't bear children (Part A), and individuals with Pulmonary Arterial Hypertension (PAH) (Part B). Specific details on who can't participate are not provided, but typically those with other serious health issues or conflicting medications would be excluded.Inclusion Criteria
I am a healthy male or a female not able to bear children.
I have PAH, am on stable PAH medication, and can walk between 150m and 450m in 6 minutes.
Exclusion Criteria
Clinically significant ECG or cardiac abnormalities
I do not have any health conditions that could affect how my body handles medication.
I have a health condition that could increase my risk in a study.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part A
Evaluation of safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers
5 weeks
Multiple visits (in-person)
Treatment Part B - Period 1
Evaluation of efficacy and safety of LTP001 in participants with pulmonary arterial hypertension
24 weeks
Regular visits (in-person)
Treatment Part B - Period 2
Continued evaluation of safety and efficacy of LTP001 in participants with pulmonary arterial hypertension
106 weeks
Regular visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing a new treatment called LTP001. In Part A, it's given to healthy participants to assess safety and tolerability. In Part B, the effects of LTP001 on people with PAH are studied. Some will receive a placebo instead of the actual drug to compare outcomes.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LTP001 Dose 3Experimental Treatment1 Intervention
Group II: LTP001 Dose 2Experimental Treatment1 Intervention
Group III: LTP001 Dose 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
matching placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
PPD Development LPAustin, TX
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Who Is Running the Clinical Trial?
Novartis PharmaceuticalsLead Sponsor
References
Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial. [2022]Pulmonary arterial hypertension is a chronic disease associated with poor long-term outcomes. Identifying predictors of long-term outcome in pulmonary arterial hypertension is important to assess disease severity and guide treatment. We investigate associations between efficacy parameters and long-term outcomes in patients with pulmonary arterial hypertension receiving riociguat in the PATENT-2 study. We also present safety and efficacy data from the final data cutoff of PATENT-2, where most patients had received at least 2 years of riociguat treatment.
Time to clinical improvement: an appropriate surrogate endpoint for pulmonary arterial hypertension medication trials. [2023]Many retrospective studies suggest that risk improvement may be a suitable efficacy surrogate endpoint for pulmonary arterial hypertension (PAH) medication trials. This prospective multicenter study assessed the efficacy of domestic ambrisentan in Chinese PAH patients and observed risk improvement and time to clinical improvement (TTCI) under ambrisentan treatment.
[Efficacy of oral bosentan for treatment of congenital heart disease-associated pulmonary arterial hypertension]. [2018]To investigate the effect of oral bosentan in the treatment of congenital heart disease-associated pulmonary arterial hypertension.
Managing pulmonary arterial hypertension and optimizing treatment options: prognosis of pulmonary artery hypertension. [2015]Survival in patients with pulmonary artery hypertension has improved, but outcomes are still suboptimal. Therapeutic focus must shift from short-term functional changes to improvements in long-term outcomes. Several outcome predictors, both at baseline and on therapy, offer guidance for clinicians treating pulmonary artery hypertension.
The current treatment of pulmonary arterial hypertension: time to redefine success. [2018]In the past decade, three classes of medications have been approved for the treatment of pulmonary arterial hypertension. A review of the clinical trial data for the prostanoids, endothelin antagonists, and phosphodiesterase-5 inhibitors has shown that all agents have similar efficacy on the 6-min walk distance over 12 to 16 weeks, which was the primary end point in the randomized clinical trials. However, little is known about their long-term efficacy or about how these drugs affect the underlying disease, if at all. Successful therapy is currently defined as an improvement in exercise tolerance over a 4-month period. Future trials need to better characterize how therapies affect the pulmonary vasculature pathologically, biologically, and hemodynamically, and whether survival is actually improved.